Could Once-Daily radiation replace Twice-Daily for breast cancer recurrence?
NCT ID NCT06129747
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times
Summary
This study is for women whose breast cancer has come back after initial breast-conserving surgery and whole breast radiation. The standard treatment after repeat surgery is radiation twice a day for 30 sessions. This trial tests whether giving radiation once a day for 15 sessions works just as well. Researchers will track side effects and whether the cancer returns in the breast.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radiation therapy
- What this could lead to
- If successful, this could offer a shorter, more convenient radiation schedule for women whose breast cancer has returned after initial treatment.
- What could go wrong
- This is a small Phase 2 study with only 55 participants, so results may not apply to everyone. The once-daily schedule might be less effective or cause different side effects than the standard approach.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 55 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants' recurrences must have histologically confirmed ductal carcinoma in-situ, invasive ductal, medullary, papillary, colloid (mucinous), tubular or mixed histologies. Three years of time must have elapsed since the end of the last course of whole breast irradiation. * Lesion size \< 3 cm treated with a partial mastectomy. Participants with invasive cancer and clinically and radiographically negative axillas do not require an axillary lymph node sampling unless they did not have prior axillary lymph node sampling (e.g. previous cancer was DCIS). Participants with DCIS as their recurrence do not require surgical assessment of the axilla. Repeat sentinel lymph node biopsy is permitted. * Negative resection margins with at least no tumor on ink or a negative re-excision. * Participants with invasive recurrence must have a negative re-staging work-up consisting of either a CT chest/abdomen and a bone scan or a PET scan. * Hormonal therapy is allowed. If chemotherapy is planned, it can be delivered either prior to or after the radiation is delivered. There must be at least 2 weeks between radiation and chemotherapy. HER2 directed therapy can be delivered concurrently with radiation. * Participants must be \> 18 years of age. Because no dosing or adverse event data are currently available on the use of breast re-irradiation in participants ≤18 years of age, children are excluded from this study. * Participants must have the ability to understand and the willingness to sign a written informed consent document. * Performance status: ECOG Performance status ≤ 2. * Life expectancy of ≥ 12months, in the opinion of and as documented by the investigator. * Not based on gender; this trial is open to any gender, defined as self-representation of gender identity. Exclusion Criteria: * Participants with nodal or distant metastatic disease \< 3 years since prior radiation. * Participants with invasive pure lobular carcinoma, extensive lobular carcinoma in-situ, extensive ductal carcinoma in-situ (spanning more than 3 cm), or uncontrolled nonepithelial breast malignancies such as lymphoma or sarcoma. * Participants with multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by at least 4 cm). Palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically or cytologically confirmed negative. * Participants with Paget's disease of the nipple. * Participants with skin involvement. * Participants with scleroderma or dermatomyositis. * Participants with psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent. * Participants who are pregnant or lactating due to potential fetal exposure to radiation and unknown effects of radiation on lactating females. * Participants with known BRCA 1/BRCA 2 mutations.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
RECRUITINGCleveland, Ohio, 44195, United States
Contact Email: •••••@•••••
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University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
RECRUITINGCleveland, Ohio, 44106-5065, United States
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